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HLA-B*58:01 Typing
Test Code93932
CPT Codes
81381
Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube, EDTA (pink-top) tube EDTA (royal blue-top) tube, sodium heparin (green-top) tube, or sodium citrate (light blue-top) tube
Minimum Volume
3 mL
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 7 days
Refrigerated: 10 days
Frozen: Unacceptable
Refrigerated: 10 days
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Clotted sample
Methodology
Screen: Allele Specific PCR • Confirmation: LABType® SSO
Setup Schedule
Sets up 3 days a week.
Clinical Significance
HLA B*58:01 has been associated with severe cutaneous adverse reactions (SCAR) in response to the drug Allopurinol. The Clinical Pharmacogenomic Implementation Consortium, CPIC, has published an article recommending genotyping prior to getting allopurinol treatment, and recommended that the drug should not be administered to patients with the HLA-B*58:01 allele. Frequency of allele varies with ethnicity: 6% to 7% in Asians, 1% in Caucasians. Similarly, the American College of Rheumatology has published guidelines for the management of gout utilizing allopurinol among other medications. They recommend HLA-B*58:01 testing in high-risk all patients of Han Chinese and Thai descent and Koreans with stage 3 or worse chronic kidney disease.